Wise Interventions and Responses to Stress

Not Applicable

Completed

• Conditions: Depression; Stress, Psychological; Stress, Physiological; Social Stress
• Interventions: Behavioral: ITP Wise intervention; Behavioral: ITP+SA Wise intervention; Behavioral: Control condition

• Registration Number: NCT04786496
• Lead Sponsor: University of Deusto

Brief Summary

This study compares the effects of two wise interventions (implicit theory of personality intervention and implicit theory of personality intervention plus self-affirmation) with a control condition in the stress responses of young adults. Responses include respiratory sinus arrhythmia, heart rate, skin conductance level, cortisol levels, and mood.

Detailed Description

Whereas several studies indicate that implicit theory of personality interventions (ITP) are promising in the prevention of depressive symptoms, evidence about the effects of the ITP intervention on stress pathways is scarce. The current study aims to elucidate the effects of ITP on psychophysiological responses to social stress in young adults during their transition to university. Based on preliminary findings that ITP was more effective among younger adolescents in reducing depressive symptoms and that a combination of ITP with self-affirmation (SA) was more effective in the prevention of other risky behaviors, the current study proposes that the addition of a SA component could increase the effectiveness of the ITP intervention when responding to stress. Thus, this study compares the effects of the ITP alone and in combination with a SA component in psychophysiological responses to a standardized social stressor (the Trier Social Stress Test, TSST). Both interventions (i.e., ITP+SA and ITP) are compared with a control condition (CC) in indicators of the autonomic nervous system (heart rate -HR-, respiratory sinus arrhythmia -RSA-, skin conductance level -SCL-), the hypothalamic-pituitary-adrenal axis (cortisol level), and subjective mood. The investigators expect that participants in both ITP interventions, and in ITP+SA intervention in particular, will display better stress responses during the stressful tasks compared with participants in the CC (i.e., lower HR and SCL increase, lower RSA suppression, and lower cortisol and negative mood increase). The investigators also expect that participants would display better recovery after the stressful tasks (i.e., higher HR and SCL decrease, and higher RSA increase).

Finally, this research will examine whether depressive symptoms moderate the effects of the intervention on stress responses. Previous research has shown that depression has been associated with dysregulated stress responses both at the autonomic nervous system and hypothalamic-pituitary-adrenal axis. Moreover, some studies have found that interventions are more effective among participants at risk to reduce both depression and stress. Therefore, the ITP intervention, alone and in combination with SA, could be more beneficial among those participants with higher levels of depressive symptoms.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-02-21
• Study Completion: 2020-02-21
• Study First Submitted: 2021-02-25
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-03
• Last Update Submitted: 2021-03-03
• Study First Posted: 2021-03-08
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Informed consent by the participants.
• To be fluent in Spanish.

Exclusion criteria:

• Having cardiovascular disease.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITP Wise intervention (Incremental Theory of Personality Intervention)	ITP Wise intervention	Wise intervention (based on ITP) consisting on several tasks to be completed individually. 30 minutes
ITP+SA Wise intervention (Incremental Theory of Personality Intervention with Self-affirmations)	ITP+SA Wise intervention	Wise intervention (based on ITP and SA) consisting on several tasks to be completed individually. 30 minutes
Control Intervention	Control condition	Educational intervention (about heritage conservation) consisting on several tasks to be completed individually. 30 minutes

Primary Outcome Measures

Name	Time	Method
Change from baseline scores of the subscale for Positive Mood of the Scale for Mood Assessment (Sanz, 2001) at recovery (immediately after the procedure -Trier Social Stress Task-).	Baseline and immediately after the math phase of the Trier Social Stress Task.	Self reported transitory positive mood measured by 4 items (assessing elation) scored on an 11-point scale from 0 (nothing) to 10 (a lot), yielding a total between 0 and 40 (with higher scores meaning higher positive mood).
Change from baseline levels of cortisol in saliva at recovery (immediately after the procedure -Trier Social Stress Task-).	Baseline and immediately after the math phase of the Trier Social Stress Task.	Participants provided saliva samples to be assayed for neuroendocrine levels to measure cortisol. They were directed to transfer saliva from their mouths to a tube. The sample tubes were carefully labelled and stored in a freezer at -25 ºC until they were sent to the Medikosta Laboratory.
Change from baseline levels of heart-rate (HR) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).	Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).	Electrocardiogram (ECG) to measure heart-rate (HR) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Change from baseline levels of skin conductance level (SCL) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).	Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).	Electrodermal Activity to measure skin conductance level (SCL) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Change from baseline levels of heart-rate variability (HRV) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).	Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).	Electrocardiogram (ECG) to measure heart-rate variability (HRV) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Change from baseline scores of the subscale for Negative Mood of the Scale for Mood Assessment (Sanz, 2001) at recovery (immediately after the procedure -Trier Social Stress Task-).	Baseline and immediately after the math phase of the Trier Social Stress Task.	Self reported transitory negative moods measured by 12 items (assessing depression, anxiety, and hostility) scored on an 11-point scale from 0 (nothing) to 10 (a lot), yielding a total between 0 and 120 (with higher scores meaning higher negative moods).

Trial Locations

Locations (1)

University of Deusto; 🇪🇸 Bilbao, Vizcaya, Spain